NDC 49288-0270

Rough Marsh Elder

Rough Marsh Elder

Rough Marsh Elder is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Iva Annua Var. Annua Pollen.

• Product ID: 49288-0270_8b59a012-60d1-4fa4-9ee7-fe89524760a2
• NDC: 49288-0270
• Product Type: Human Prescription Drug
• Proprietary Name: Rough Marsh Elder
• Generic Name: Rough Marsh Elder
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1992-04-13
• Marketing Category: BLA / BLA
• Application Number: BLA102223
• Labeler Name: Antigen Laboratories, Inc.
• Substance Name: IVA ANNUA VAR. ANNUA POLLEN
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0270-5

50 mL in 1 VIAL, MULTI-DOSE (49288-0270-5)

• Marketing Start Date: 1992-04-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49288-0270-2 [49288027002]

Rough Marsh Elder INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-04-13
• Inactivation Date: 2019-10-21

NDC 49288-0270-3 [49288027003]

Rough Marsh Elder INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-04-13
• Inactivation Date: 2019-10-21

NDC 49288-0270-4 [49288027004]

Rough Marsh Elder INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-04-13
• Inactivation Date: 2019-10-21

NDC 49288-0270-5 [49288027005]

Rough Marsh Elder INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-04-13
• Inactivation Date: 2019-10-21

NDC 49288-0270-1 [49288027001]

Rough Marsh Elder INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-04-13
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
IVA ANNUA VAR. ANNUA POLLEN	.1 g/mL

OpenFDA Data

• SPL SET ID: b8e9933d-eeb3-4379-aaa4-5dfb1179683f
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • 1EDY616508
  • U2AI3H2J5Y
  • 92N6W6KO2G
  • BML0J15H8W
  • 380W4HYR6N
  • GG8WX068MX
  • YB1308W43O
  • ZIO18VN6HJ
  • 644CZ16IR5
  • 098LKX5NCN
  • DO87T1U2CI
  • G515RAI9FY
  • R6H8O3GVL9
  • UVC3Z60VTX
  • YI19RB8YFD
  • JQ87AA60GU
  • 5AN5LR8L3F
  • K20Y81ACO3
  • 81GS97HVFO
  • RX18M46K8L
  • 86LWA5503I
  • 2MH135KC6G
  • V825XJG64G
  • 1GH3WV23KH
  • 2QOF601J1M
  • M3S672G75O
  • WIB701MW2H
  • WQ3S5294XY
  • N52MIQ81ZW
  • 63TBJ590BL
  • O4AB4546TP
  • DNB59M1NVU
  • 26U0BU8G83
  • B67NF86HF0
  • 57KIJ4772H
  • ANT994T71D
  • KU1V1898XX
  • UU78E56M7L
  • 13KFG30UBR
  • 28D6K7E9IP
  • 73B14PX5FW
• RxNorm Concept Unique ID - RxCUI:
  • 1014742
  • 851933
  • 852049
  • 1014746
  • 851937
  • 852512
  • 1014339
  • 852554
  • 852596
  • 1014705
  • 852535
  • 995746
  • 852082
  • 852542
  • 852240
  • 897378
  • 897506
  • 897319
  • 899534
  • 851929
  • 995611
  • 896120
  • 898010
  • 852010
  • 898329
  • 851988
  • 852014
  • 851984
  • 1232608
  • 1014769
  • 896224
  • 852032
  • 1115931
  • 852216
  • 896249
  • 852212
  • 852745
  • 851941
  • 897953
  • 852077
  • 852099
  • 897307
  • 852090
  • 1098396
  • 1006353
  • 1117086
  • 885753
  • 897991
  • 895729
  • 1115927
  • 895922
  • 1006498
  • 852001
  • 1014450
  • 852161
  • 897394
  • 851972
  • 852023
  • 896259
  • 901035
  • 995604

Pharmacological Class

• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]

NDC Crossover Matching brand name "Rough Marsh Elder" or generic name "Rough Marsh Elder"

NDC	Brand Name	Generic Name
36987-3253	Rough Marsh Elder	Rough Marsh Elder
36987-3254	Rough Marsh Elder	Rough Marsh Elder
36987-3255	Rough Marsh Elder	Rough Marsh Elder
36987-3256	Rough Marsh Elder	Rough Marsh Elder
36987-3257	Rough Marsh Elder	Rough Marsh Elder
36987-3258	Rough Marsh Elder	Rough Marsh Elder
36987-3259	Rough Marsh Elder	Rough Marsh Elder
36987-3260	Rough Marsh Elder	Rough Marsh Elder
49288-0270	Rough Marsh Elder	Rough Marsh Elder
49288-0271	Rough Marsh Elder	Rough Marsh Elder